SGMS Software Development
With the pressure to bring new instruments or features to market, medical devices company must constantly and rapidly grow their software development staff. This is not always possible for many different reasons: shortage of qualified resources, budget constraint, etc. It is difficult to maintain a large development group to adequately cater for a “peak and valley” workload environment. The solution is obvious: get temporary external help. However, it is easier said than done! While a viable and logical solution, risk will be high and complication may arise if the right “help” has not been carefully chosen.
What characterizes the “help” as the right “help”? The right “help” must have the following:
- Superior skill level to “hit the ground running.”
- Adequate business domain knowledge.
- Ability to quickly develop a good synergy with the client’s to ensure great work collaboration.
- Ability to professionally perform technology transfer to hand over the work done to the client by means of appropriate training documentation allowing the client to adequately and effectively maintain the software.
Having all the above characteristics, specifically for medical device software development, we believe that we are the right “help”.
While having significant experiences in software development in many industries, we focus our offering to the medical devices industry. Why? Because we believe that it is in this industry segment that:
- We have the most experience
- We have had the most and biggest successes
- We can make the most difference for our clients
- Our clients need us the most
Core Competencies
Domains
- Medical Devices
- Real-time Embedded Systems
- Laboratory Automation Systems (LAS)
- Laboratory Information Systems (LIS)
- Relational Database Management Systems (RDBMS)
- Network Programming
- Communication Protocols
- Graphical User Interface
- Medical Device Technology Transfer
Software Technologies
- C/C++/C++11
- Java
- C#.NET
- Multithread Programming (Posix, Unix)
- TCP/IP
- CAN/CANopen
- Object-Oriented Software Engineering
- UML
- Qt 4.x & 5.1,
- OpenCV
- .Net
- Unix/Linux
- Microsoft Windows
- ASTM
- HL7
Miscellaneous Programming & Scripting Languages
- JavaScript
- PHP
- XML
- HTML
- Perl
- Python
- SQL
- Unix Shells
- Ant
SDLC Activities
- Requirement Engineering: Elicitation, Analysis, Management, and Traceability
- Software Architecture
- Software Detailed Design
- Hazard Analysis and Risk Assessment
- Code Construction
- Automated Unit and Integration Testing
- Software Verification
- System Validation
Software Applications
- Oracle
- DB2
- SQL Server
- MySql
- Firebird
- SQLite
- MagicDraw
- Microsoft Office
- Microsoft Project
- Microsoft Visio
- GCC
- GDB
- Coverity Static Analysis
- Valgrind
- Purify
- Quantify
- CVS
- Visual Source Safe
- Mercurial
- Subversion
- Git
- ClearCase
- ClearDDTS
- Visual Studio .NET
- NetBeans
- Eclipse
Hardware
- ARM
- Intel
- Sun Microsystems
- IBM RS6000
Pertinent Medical Software Regulations and Standards
- Title 21 – CFR Part 11
- Title 21 – CFR Part 820
- Title 42 – CFR part 3 section 3.10 – 3.552
- Title 45 – CFR part 164 – 164.102 – 164.534
- ISO 13485:2003
- ISO 14971:2007
- Medical Device Directive: 90/385/EEC; 98/79/EC
Service Types and Pricing Models
We provide three types of service with corresponding pricing models to support our clients’ need:
- Outsource: Fixed (based on work scope)
- On-Site Staff Augmentation: Hourly
- Off-Site Staff Augmentation: Hourly
Please contact us to discuss about your needs.